Surgery for Relapsed Ovarian Cancer in Precision

Inclusion Criteria:

• Arm 1 (criteria-fulfilled, CF)

1. Age at recurrence ≥ 18 years, <80 years.

2. Patients with platinum-sensitive, first relapsed epithelial ovarian, primaryperitoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as thosewith treatment -free interval of 6 months or more.

3. If the patient had previous PARPi maintenance therapy, disease progressionshould occurring at lease 3 months after the prior PARPi withdrawal.

4. BRCA1/2 wild type (both germline and somatic)

5. Homologous Recombination Deficiency (HRD) is available

6. Patients must provide archived or fresh tumor tissue samples for biomarkerdetection.

7. PD-L1 positive (if either at least 1% of assessed tumour cells expressedmembranous PD-L1, at least 5% of immune cells within the tumour area expressedPD-L1, or both) and number of intraepithelial CD8+ tumor-infiltratinglymphocytes (TILs) per high-powered field ≥ 6.

8. Assessed by the experienced surgeons, complete resection of all recurrentdisease is possible (predicted by iMODEL score or by PET/CT).

9. ECOG performance status of 0 to 2

10. Adequate bone marrow, liver, and renal function to receive combinedimmunotherapy

11. Written informed consent

• Arm 2 (compassionate use, CU), Similar to cohort 1, except for:

1. If the patient had previous PARPi maintenance therapy, disease progressionshould occurring within 3 months after the prior PARPi withdrawal or during thePARPi maintenance therapy.

2. PD-L1 positive or number of intraepithelial CD8+ TILs per high-powered field ≥

• Arm 3 (real word) Patients who meet the inclusion criteria but refuse to participatein the phase II CF and CU cohorts.

Exclusion Criteria:

1. Patients with borderline, low-grade tumors, clear cell carcinoma, as well asnon-epithelial tumors.

2. Patients with platinum-resistant or refractory diseases.

3. Lack of tumor samples (archived and/or recently obtained) for biomarker detection.

4. Previous administration of immunotherapy

5. Patients have been vaccinated with the live vaccine or received anti-tumor treatmentwithin 4 weeks before the first administration.

6. Synchronous or metachronous (within 5 years) malignancy, symptomatic or uncontrolledvisceral metastases that require simultaneous treatment, other than carcinoma insitu or breast cancer (without any signs of relapse or activity).

7. Patients with parenchymal metastases and life-threatening complications in shortterm.

8. Any other concurrent medical conditions contraindicating surgery, chemotherapy, orimmunotherapy that could compromise the adherence to the protocol.

9. Patients are known to be allergic to the active ingredients or excipients ofSintilimab.

10. HRD status is not available.

11. Any medication induced considerable risk of surgery, e.g. estimated bleeding due tooral anticoagulating agents or bevacizumab.

12. Patients for interval-debulking, or for second-look surgery, or palliative surgeryplanned.

13. Impossible to assess the resectability of recurrent disease or evaluate the score.Radiological signs suggesting complete resection is impossible.